Evaluation of Effect of Non-surgical Periodontal Treatment on Patient's Self Perception of Esthetics

NCT06477510 | Not Yet Recruiting

• 1 other identifier: Ayeshaperio_12
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

Non-surgical periodontal treatment is a fundamental part of periodontal therapy,including supportive therapy. It has been proven to be efficacious in reducing inflammation, probing pocket depth and number of diseased sites in patients affected by periodontitis, often limiting the need for additional treatment approaches. However,despite being such a widely administered treatment, the effect of non-surgical periodontal treatment on patient reported outcomes has remained restricted to parameters such as pain and sensitivity only, with patient's perception of aesthetics remaining largely unexplored. Focusing only on physical periodontal measurements, leaves the true impact of periodontitis as well as its treatment on patient's well-being largely under recognized. With the development of the periodontal aesthetics perception scale (PAPS), it is possible to assess the results in a standardized manner.Therefore, the goal of this study (prospective-interventional ) is to to assess the patient's self-perception of aesthetics using a standardized tool after non surgical periodontal treatment and how much of changes in aesthetics are perceived by the patient. This would be helpful in understanding and managing patient expectations. Also, utilizing a standardized tool would reduce heterogeneity bias by providing comparable data between studies for future research on understanding patient preferences.

Conditions

Periodontitis

Keywords

aesthetics; patient-reported outomes

Outcome Measures

Primary Outcomes (3)

• Patient's perception of aesthetics by PAPS score (Periodontal Aesthetic Perception Scale)

  Assess Patient's perception of aesthetics by PAPS score (Periodontal Aesthetic Perception Scale) in Indian population

  12-18 months

• Patient's perception of aesthetics by Numeri rating scale

  Assess Patient's perception of aesthetics by Numeric rating scale

  12-18 months

• Patient's perception of aesthetics by Global transition scale

  Assess Patient's perception of aesthetics by Global transition scale

  12-18 months

Secondary Outcomes (1)

• To correlate self-reported perception of esthetics with clinical periodontal parameters (CAL, BOP, PPD, gingival phenotype, gingival recession, interdental papillary height, gingival pigmentation and gingival display).

  12-18 months

Study Arms (1)

Test group

EXPERIMENTAL

self perception of esthetics and clinical periodontal parameters will be evaluated in patients with stage I/II/III periodontitis at baseline and post non surgical periodontal therapy.

Procedure: non-surgical periodontal therapy

Interventions

non-surgical periodontal therapy PROCEDURE

change in self perception of esthetics and clinical periodontal parameters will be assessed after non-surgical periodontal therapy.

Also known as: scaling and root planing

Test group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patients in the age group of (18-60 years).
• Presence of ≥ 18 natural teeth
• Ability and willingness to give written informed consent
• Patients belonging to Stage I/II/III periodontitis.
• Systemically healthy individuals.

You may not qualify if:

• Smokers.
• Patients who have received periodontal treatment within 6 months or taken antibacterial drugs within last 3 months.
• Patient with psychological or systemic disease that can influence the outcome of non-surgical periodontal therapy.
• Presence of tooth loss or caries or prosthesis of any type in anterior teeth.
• Pregnant females or on oral contraceptive pills or hormone replacement therapy.
• Physically and cognitively impaired patients.
• Teeth with need for endodontic treatment.
• Teeth with Endo-perio lesion.
• Patients with no aesthetic concerns.

Sponsors & Collaborators

• Postgraduate Institute of Dental Sciences Rohtak: lead

Study Sites (1)

Post Graduate Institute of Dental Sciences

Rohtak, Haryana, 124001, India

Location

MeSH Terms

Conditions

Periodontitis

Interventions

Tooth Exfoliation; Root Planing

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Dental Physiological Phenomena; Digestive System and Oral Physiological Phenomena; Dental Scaling; Dental Prophylaxis; Periodontics; Dentistry; Subgingival Curettage; Preventive Dentistry

Study Officials

• Ayesha Ahmed

  PGIDS, Rohtak

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dr.Aditi Sangwan

CONTACT

9996002408; aditidalal86@yahoo.co.in

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The study population will include consecutive subjects referred to the Department of Periodontics, PGIDS, Rohtak for clinical evaluation. The patients will be screened according to the inclusion and exclusion criteria for eligibility to participate in the study. All participants will be informed about the purpose of the study and only individuals who provide written informed consent prior to the start of the study will be included. After validation of the PAPS scale, patients with Stage I/II/III Periodontitis will be selected, and PAPS score recorded at baseline, then at 4 weeks and 3 month post non-surgical periodontal treatment and clinical parameters recorded at baseline and 3 month post non-surgical periodontal treatment with ultrasonic scaler or hand instruments as required.

Study Record Dates

• First Submitted: May 23, 2024
• First Posted: June 27, 2024
• Study Start: July 1, 2024
• Primary Completion: October 1, 2025
• Study Completion: December 1, 2025
• Last Updated: June 27, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)